A post hoc analysis evaluated the safety, efficacy, and tolerability of IDP-126 gel in Black patients with moderate to severe acne, of which there are limited data and literature describing its outcomes in this patient population.
A fixed-dose of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (IDP-126) gel was safe, well-tolerated, and efficacious in reducing investigator-assessed erythema in Black patients with acne, according to a poster presented at the 2023 Society of Dermatology Physician Assistants Fall Conference in Nashville, TN.1
According to study authors Callender et al, literature and data describing patient outcomes for patients with skin of color in relation to this fixed-dose combination are limited. It is important, they noted, to be conscientious of minimizing skin irritation in patients with more melanin-rich skin due to risk of pigmentary alterations such as hyperpigmentation and hypopigmentation.
The pooled, post hoc analysis examined and analyzed the results of 2 identical phase 3 studies (NCT04214639; NCT04214652) involving patients ages 9 years and older with moderate to severe acne as defined by a score of 3 or 4 for on the Evaluator’s Global Severity Score scale.
Patients were randomized using a 2:1 ratio, wherein 2 patients were assigned to once-daily treatment with IDP-126 gel for every 1 patient assigned to treatment with a vehicle control gel. Both patient groups were provided with identical cleansers, lotions, and sunscreens on an as-needed basis.
Of 363 patients in the pooled intent-to-treat population, approximately 14.9% self-identified as Black.
As a result of treatment with IDP-126 gel, patients self-identifying as Black experienced improvements in erythema as assessed by investigators. Despite clinical improvements in erythema, investigators noted that no increases or incidences of hyperpigmentation or hyperpigmentation were evident. Rates of erythema had decreased by more than 10% from baseline to week 12 of treatment.
IDP-126 was deemed both safe and well-tolerated in this patient population, with only mild and moderate treatment-emergent adverse events (TEAE) reported among Black patients in the studies. The most commonly-reported TEAE was application site pain, followed by application site pruritus.
“Minimizing irritation is a key goal in managing acne in patients with skin of color, given the higher risk of pigmentary alterations in melanin-rich skin,” study authors wrote. “Despite the limited number of self-identified Black participants in these phase 3 studies, these post hoc analyses add valuable information to the limited literature describing treatment effects and tolerability of fixed-dose combination acne treatments in Black individuals.”